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Spinal Anesthesia Induced Hypotension During Cesarean Section

Phase 4
Completed
Conditions
Hypotension
Interventions
Other: Colloid administration
Other: Crystalloid administration
Registration Number
NCT00846651
Lead Sponsor
Milton S. Hershey Medical Center
Brief Summary

The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.

Detailed Description

Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt to prevent low blood pressure using phenylephrine infusion that has been shown to be effective in recent research. In addition to receiving phenylephrine one group of patients will receive standard salt solution (Ringer's lactate solution), while the other group will receive a different, intravenous fluid called hydroxyethylstarch.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
82
Inclusion Criteria
  • American Society of Anesthesiologists (ASA) physical status I and II
  • Elective cesarean section
  • Weight 50-120 kg, Height 150-180 cm
  • Normal singleton pregnancy
  • Beyond 36 weeks gestation
  • No known fetal abnormalities
  • Ages 18-35
Exclusion Criteria
  • Contraindications to spinal anesthesia
  • Multiple gestation, placenta previa, accreta
  • Pregnancy induced hypertension or preeclampsia
  • Diabetes mellitus, cardiovascular diseases
  • Coagulopathy
  • Spinal cord abnormalities, spinal surgery, or preexisting neurological dysfunction
  • Baseline HR <65
  • Failed spinal anesthesia/inadequate sensory block for surgery
  • History of abnormal bleeding
  • History of adverse reactions to hydroxyethylstarch

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
colloid, then phenylephrine infusionColloid administrationcolloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
crystalloid, then phenylephrine infusionCrystalloid administrationcrystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
colloid, then phenylephrine infusionphenylephrine infusioncolloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
crystalloid, then phenylephrine infusionphenylephrine infusioncrystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Primary Outcome Measures
NameTimeMethod
Incidence of Maternal Hypotensionparticipants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Secondary Outcome Measures
NameTimeMethod
Incidence of Maternal Bradycardiaparticipants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Fetal Cord Blood pHdelivery of the baby
Dosage of Phenylephrine Usedparticipants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
APGAR ScoresApgar scores were assessed at 1 amd 5 min after delivery of the baby

The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration).

Incidence of Maternal Nausea and Vomitingparticipants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Trial Locations

Locations (1)

PennState Hershey Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

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